Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors

A Phase 1 study testing ASP8374 in people with Advanced Solid Tumors, run by Astellas Pharma Inc at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the tolerability and safety profile and to characterize the pharmacokinetic profile of ASP8374 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors. This study also evaluates the anti-tumor effect of ASP8374. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: ASP8374
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteJapan
Study dates: 5 Aug 2019to 12 Jun 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit for his/her specific tumor type.
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days prior to initiation of study drug administration. A subject with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation-positive non-small cell lung cancer (NSCLC) is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor therapy until 4 days prior to initiation of study drug administration.
Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks prior to initiation of study drug administration.
Subject's adverse events (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to initiation of study drug administration.
Subject with metastatic castration resistant prostate cancer (mCRPC) (positive bone scan and/or soft tissue disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI)) meets both of the following:

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Subject has serum testosterone ≤ 50 ng/dL at screening.
Subject has had an orchiectomy or plans to continue androgen deprivation therapy (ADT) for the duration of study treatment.
Subject has adequate organ function prior to initiation of study drug administration per specified laboratory values criteria within 7 days prior to initiation of study drug administration. If a subject has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion.
A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
Female subject must agree not to breastfeed starting at screening and throughout the treatment period, and for 6 months after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the treatment period, and for 6 months after the final study drug administration.
Male subject with female partner(s) of childbearing potential (including breastfeeding partner(s)) must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the treatment period, and for 6 months after the final study drug administration.
Male subject with a pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the treatment period and for 6 months after the final study drug administration.
Subject agrees not to participate in another interventional study while receiving study drug in present study (subjects who are currently in the follow-up period of an interventional clinical study are allowed).

Who cannot join

Subject weighs < 45 kg at screening.
Subject has received investigational therapy within 21 days prior to initiation of study drug administration. (A subject with EGFR activating mutations or a subject with an ALK mutation is allowed to remain on an investigational EGFR TKI or ALK inhibitor until 4 days prior to initiation of study drug administration.)
Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to initiation of study drug administration. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) are allowed.
Subject has symptomatic central nervous system (CNS) metastases or subject has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Subjects with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to initiation of study drug administration and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
Subject has an active autoimmune disease. Subjects with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.
Subject was discontinued from prior immunomodulatory therapy due to a grade ≥ 3 toxicity that was mechanistically related (e.g., immune related) to the agent.

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Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP8374 or severe hypersensitivity reaction to treatment with another monoclonal antibody.
Subject has a known history of Human Immunodeficiency Virus.
Subject is positive for Hepatitis B virus (HBV) antibodies and surface antigen (including acute HBV or chronic HBV) or Hepatitis C virus ([HCV] ribonucleic acid [RNA]). HVC RNA testing is not required in subjects with negative Hepatitis C antibody testing. HBV antibodies are not required in subjects with negative Hepatitis B surface antigen (HBsAg).
Subject has received a live vaccine against infectious diseases within 28 days prior to initiation of study drug administration.
Subject has a history of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis.
Subject has an infection requiring systemic therapy within 14 days prior to initiation of study drug administration.
Subject has received a prior allogeneic bone marrow or solid organ transplant.
Subject is expected to require another form of antineoplastic therapy while on study treatment.
Subject has had a myocardial infarction or unstable angina within 6 months prior to initiation of study drug administration or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Subject has any condition which makes the subject unsuitable for study participation.
Subject has had a major surgical procedure and has not completely recovered within 28 days prior to initiation of drug administration.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Site JP81001
Chuo-ku, Tokyo

Other trials in Japan

About this study

Official title: A Phase 1, Open Label Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors

This study also evaluates the anti-tumor effect of ASP8374.

Read the detailed description

This study consists of two arms (Arm A: ASP8374 dose A; and Arm B: ASP8374 dose B). Arm B would only be opened if Arm A is deemed tolerable.

The study consists of 2 periods: Screening (up to 28 days) and treatment period. The Dose Limiting Toxicities (DLT) observation period is set at the beginning of the treatment period. A subject can continue to participate in the study after the end of the DLT observation period until discontinuation criteria are met. After discontinuation of study drug treatment, all subjects will complete an end of treatment visit and safety follow-up visits.

Conditions: Advanced Solid Tumors
Being tested: ASP8374
Keywords: Pharmacokinetics, Tumors, Oncology, Safety and tolerability, Locally advanced or metastatic solid tumor, ASP8374
Medical subject headings: Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASP8374Drug
Intravenous

Study groups in NCT03945253
Study group	Role	What they receive
ASP8374-dose A	Experimental	Participants will receive dose A of ASP8374 solution intravenously on day 1 of every 3-week cycle. Receives: Drug: ASP8374
ASP8374-dose B	Experimental	Participants will receive dose B of ASP8374 solution intravenously on day 1 of every 3-week cycle. Receives: Drug: ASP8374

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability assessed by Dose Limiting Toxicity (DLT)
DLT is graded using National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] Version 4.03. The DLT observation period may be increased if deemed appropriate by the Tolerability Evaluation Meeting.
Measured: Up to 21 days
Safety and tolerability assessed by adverse events (AEs)
An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Measured: Up to 30 days after the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first (a maximum of 109 weeks)
Safety and tolerability assessed by immune-related AEs (irAEs)
Most frequent immune-related AEs observed with currently approved checkpoint inhibitors include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis, and endocrinopathies .
Measured: Up to 30 days after the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first (a maximum of 109 weeks)
Safety and tolerability assessed by serious adverse events (SAEs)
An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, life-threatening, persistent or significant disability/incapacity or substantial disruption, congenital anomaly or birth defect, hospitalization, or medically important event
Measured: Up to 90 days after the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first (a maximum of 117 weeks)
Number of participants with laboratory value abnormalities and/or adverse events related to treatment
Number of patients with potentially clinically significant laboratory values.
Measured: Up to 30 days after the last dose of study drug (a maximum of 109 weeks)
Safety and tolerability assessed by 12-lead electrocardiogram (ECG)
ECGs should be obtained after the subject has rested quietly and is awake in a fully supine position (or semi-recumbent, if supine is not tolerated) for 10 minutes before the first ECG from a triplicate or single ECG. Any clinically significant adverse changes on the ECS will be reported as (serious) AEs.
Measured: Up to end of treatment period (a maximum of 105 weeks)
Number of participants with vital signs abnormalities and/or adverse events related to treatment
Number of patients with potentially clinically significant vital sign values.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
Number of participants with physical exam abnormalities and/or adverse events related to treatment
Number of patients with potentially clinically significant physical exam values.
Measured: Up to end of treatment period (a maximum of 105 weeks)
Safety and tolerability assessed by eastern cooperative oncology group (ECOG) performance status
The ECOG Scale [Oken, 1982] will be used to assess performance status ; 0=Fully active, able to carry on all predisease performance without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, (e.g., light housework, office work); 2=Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
Measured: Up to 30 days after the last dose of study drug (a maximum of 109 weeks)
Pharmacokinetics (PK) of ASP8374 in serum: AUClast
AUClast: area under the concentration-time curve from the time of dosing up to the last measurable concentration. AUClast will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: AUCinf
AUCinf: AUC from the time of dosing extrapolated to time infinity. AUCinf will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: AUCinf(%extrap)
AUCinf(%extrap): Percentage of AUCinf due to extrapolation from the last measurable concentration to time infinity
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: AUCtau
AUCtau: AUC from the time of dosing to the start of the next dosing interval at multiple dose conditions. AUCtau will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: Cmax
Cmax: maximum concentration. Cmax will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: Ctrough
Ctrough: trough concentration. Ctrough will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: tmax
tmax: time of maximum concentration. Tmax will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: t1/2
t1/2: terminal elimination half-life. t1/2 will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: tlast
tlast: time of last measurable concentration. tlast will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: CL
CL: total clearance after intravenous dosing. CL will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: Vz
Vz: volume of distribution after intravenous dosing during the terminal elimination phase. will be derived from the PK serum samples collected. Vz will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
PK of ASP8374 in serum: Vss
Vss: volume of distribution at steady state after intravenous dosing. Vss will be derived from the PK serum samples collected.
Measured: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)

Secondary outcomes (2)

Percent change in tumor size from baseline
Tumor size is defined as the sum of the diameters of all target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percent change from baseline in tumor size will be calculated for subjects with target lesions at baseline.
Measured: Up to end of treatment period (a maximum of 105 weeks)
Best overall response (BOR) per RECIST 1.1 and 'immune' Response Evaluation Criteria in Solid Tumors (iRECIST)
BOR is defined as the best response recorded from the start of the study treatment until the end of treatment.
Measured: Up to end of treatment period (a maximum of 105 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 201912 Jun 2020

First posted10 May 2019
Study start5 Aug 2019
Primary completion12 Jun 2020
Study completion12 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03945253
Sponsor's protocol ID: 8374-CL-0102
Status last verified: Nov 2024
First submitted: 7 May 2019
Last updated: 13 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open Label Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03945253
Acronym / sponsor ID: 8374-CL-0102
Conditions: Advanced Solid Tumors
Keywords: Pharmacokinetics, Tumors, Oncology, Safety and tolerability, Locally advanced or metastatic solid tumor, ASP8374
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Study start: 5 Aug 2019 (actual)
Primary completion: 12 Jun 2020 (actual)
Study completion: 12 Jun 2020 (actual)
First posted: 10 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study also evaluates the anti-tumor effect of ASP8374.

Detailed description

This study consists of two arms (Arm A: ASP8374 dose A; and Arm B: ASP8374 dose B). Arm B would only be opened if Arm A is deemed tolerable.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ASP8374-dose A	Experimental	Drug: ASP8374Participants will receive dose A of ASP8374 solution intravenously on day 1 of every 3-week cycle.
ASP8374-dose B	Experimental	Drug: ASP8374Participants will receive dose B of ASP8374 solution intravenously on day 1 of every 3-week cycle.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit for his/her specific tumor type.
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days prior to initiation of study drug administration. A subject with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation-positive non-small cell lung cancer (NSCLC) is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor therapy until 4 days prior to initiation of study drug administration.
Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks prior to initiation of study drug administration.
Subject's adverse events (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to initiation of study drug administration.

Key exclusion criteria (17 listed)

Subject weighs < 45 kg at screening.
Subject has received investigational therapy within 21 days prior to initiation of study drug administration. (A subject with EGFR activating mutations or a subject with an ALK mutation is allowed to remain on an investigational EGFR TKI or ALK inhibitor until 4 days prior to initiation of study drug administration.)
Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to initiation of study drug administration. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) are allowed.
Subject has symptomatic central nervous system (CNS) metastases or subject has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Subjects with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to initiation of study drug administration and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
Subject has an active autoimmune disease. Subjects with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ASP8374Intravenous	Drug	ASP8374-dose A, ASP8374-dose B

Primary outcome

Safety and tolerability assessed by Dose Limiting Toxicity (DLT)
Time frame: Up to 21 days
DLT is graded using National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] Version 4.03. The DLT observation period may be increased if deemed appropriate by the Tolerability Evaluation Meeting.
Safety and tolerability assessed by adverse events (AEs)
Time frame: Up to 30 days after the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first (a maximum of 109 weeks)
An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Safety and tolerability assessed by immune-related AEs (irAEs)
Time frame: Up to 30 days after the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first (a maximum of 109 weeks)
Most frequent immune-related AEs observed with currently approved checkpoint inhibitors include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis, and endocrinopathies .
Safety and tolerability assessed by serious adverse events (SAEs)
Time frame: Up to 90 days after the last dose of study drug or until initiation of a new anti-cancer treatment, whichever comes first (a maximum of 117 weeks)
An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, life-threatening, persistent or significant disability/incapacity or substantial disruption, congenital anomaly or birth defect, hospitalization, or medically important event
Number of participants with laboratory value abnormalities and/or adverse events related to treatment
Time frame: Up to 30 days after the last dose of study drug (a maximum of 109 weeks)
Number of patients with potentially clinically significant laboratory values.
Safety and tolerability assessed by 12-lead electrocardiogram (ECG)
Time frame: Up to end of treatment period (a maximum of 105 weeks)
ECGs should be obtained after the subject has rested quietly and is awake in a fully supine position (or semi-recumbent, if supine is not tolerated) for 10 minutes before the first ECG from a triplicate or single ECG. Any clinically significant adverse changes on the ECS will be reported as (serious) AEs.
Number of participants with vital signs abnormalities and/or adverse events related to treatment
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
Number of patients with potentially clinically significant vital sign values.
Number of participants with physical exam abnormalities and/or adverse events related to treatment
Time frame: Up to end of treatment period (a maximum of 105 weeks)
Number of patients with potentially clinically significant physical exam values.
Safety and tolerability assessed by eastern cooperative oncology group (ECOG) performance status
Time frame: Up to 30 days after the last dose of study drug (a maximum of 109 weeks)
The ECOG Scale [Oken, 1982] will be used to assess performance status ; 0=Fully active, able to carry on all predisease performance without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, (e.g., light housework, office work); 2=Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
Pharmacokinetics (PK) of ASP8374 in serum: AUClast
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
AUClast: area under the concentration-time curve from the time of dosing up to the last measurable concentration. AUClast will be derived from the PK serum samples collected.
PK of ASP8374 in serum: AUCinf
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
AUCinf: AUC from the time of dosing extrapolated to time infinity. AUCinf will be derived from the PK serum samples collected.
PK of ASP8374 in serum: AUCinf(%extrap)
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
AUCinf(%extrap): Percentage of AUCinf due to extrapolation from the last measurable concentration to time infinity
PK of ASP8374 in serum: AUCtau
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
AUCtau: AUC from the time of dosing to the start of the next dosing interval at multiple dose conditions. AUCtau will be derived from the PK serum samples collected.
PK of ASP8374 in serum: Cmax
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
Cmax: maximum concentration. Cmax will be derived from the PK serum samples collected.
PK of ASP8374 in serum: Ctrough
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
Ctrough: trough concentration. Ctrough will be derived from the PK serum samples collected.
PK of ASP8374 in serum: tmax
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
tmax: time of maximum concentration. Tmax will be derived from the PK serum samples collected.
PK of ASP8374 in serum: t1/2
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
t1/2: terminal elimination half-life. t1/2 will be derived from the PK serum samples collected.
PK of ASP8374 in serum: tlast
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
tlast: time of last measurable concentration. tlast will be derived from the PK serum samples collected.
PK of ASP8374 in serum: CL
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
CL: total clearance after intravenous dosing. CL will be derived from the PK serum samples collected.
PK of ASP8374 in serum: Vz
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
Vz: volume of distribution after intravenous dosing during the terminal elimination phase. will be derived from the PK serum samples collected. Vz will be derived from the PK serum samples collected.
PK of ASP8374 in serum: Vss
Time frame: Up to 90 days after the last dose of study drug (a maximum of 117 weeks)
Vss: volume of distribution at steady state after intravenous dosing. Vss will be derived from the PK serum samples collected.

2 secondary outcomes

Percent change in tumor size from baseline
Time frame: Up to end of treatment period (a maximum of 105 weeks)
Best overall response (BOR) per RECIST 1.1 and 'immune' Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: Up to end of treatment period (a maximum of 105 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Related trials for Advanced Solid Tumors

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Medical Lead study director

Astellas Pharma Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP8374 in people with Advanced Solid Tumors, run by Astellas Pharma Inc at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability assessed by Dose Limiting Toxicity (DLT) (time frame: Up to 21 days). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03945253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.